Z-1983-2026Class II

BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use

Name: Z-1983-2026 BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
Creator: Becton Dickinson & Co.
Published: 2026-04-07
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2026-04-07 / Open, Classified / root cause: packaging

FDA source

Becton Dickinson & Co. began a recall of BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use on 2026-04-07. FDA classified it as Class II and gives the reason as "BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1983-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-07
Posted: 2026-04-29
Recalling firm: Becton Dickinson & Co
Product: BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
Product code: KZJ Device, Gas Generating
Reason for recall: BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On 04/07/2026, BD sent URGENT: Medical Device Correction letters to customers and distributors. Consignees were instructed that there are no recommendations for retrospective chart review or repeat patient testing. They are to verify incubation atmospheres by incorporating the use of appropriate gas indicators as part of routine laboratory quality control practices. Each BD GasPak EZ Gas Generating Pouch System should be tested periodically for its ability to provide adequate conditions for the growth of target organisms. For CO2 incubation, laboratories may use BD CO2 Indicators (Catalog No. 271055), along with the impacted catalog 260684, to verify sufficient CO2 presence in the environment. If conditions are not confirmed or are suspected to be out of specification, laboratories should repeat incubation using alternative validated methods or established laboratory procedures to ensure organism recovery. Additionally, consignees were instructed to ensure the contents of the notification are read and understood, share this notification with the facility network and forward it to any customers to whom product may have been distributed, and complete and return the Customer Response Form. Distributors were instructed to ensure the notification is read and understood, identify all customers that purchased any affected product, and provide a copy of the attached customer letter to all customers who received the affected lots to advise them of this Product Advisory on BD's behalf. BD is investigating the root cause and will implement appropriate corrective actions to prevent recurrence of this issue. BD GasPak catalog numbers 260684 and 260685 are currently on backorder due to seal integrity challenges identified in some batches following a recent overhaul of supplier manufacturing equipment. BD anticipates resumption of product shipments by the end of March 2026, with full recovery expected by June 2026.
Quantity in commerce: 2,200 units
Distribution: Worldwide distribution - US Nationwide and the country of Hong Kong.
Product codes and lots: Catalog Number: 260685; UDI-DI: 30382902606858; Lot Number: 5329863.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1983-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1982-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29
Z-1983-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29

Product code KZJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)